Quality Assurance Specialist

12 hours ago

Makati City, National Capital Region, Philippines beBeeQuality Full time $105,000 - $135,000

Job Title:

Quality Assurance Specialist

The Quality Assurance Specialist plays a pivotal role in championing quality within the organisation, ensuring that our corporate mission is fulfilled. Key responsibilities include monitoring and maintaining our purpose-built Quality Management System (QMS) in accordance with ISO 13485 and ISO 9001 standards.

  • Develop and implement audit programs, conduct internal audits, and coordinate external audits to ensure overall compliance to standard operating procedures.
  • Identify opportunities for improvement in company processes and systems, collaborating with subject matter experts to drive implementation.
  • Manage CAPA related activities, providing guidance on relevant standards and regulations for product developments.
  • Facilitate risk management and identification of product user needs, requirements verification and validation activities, and traceability throughout development.
  • Oversee quality management for medical device development according to regulatory requirements such as CE MDR, FDA, and TGA, and industry standards including ISO 13485, IEC 60601, and IEC 62304.
  • Calibrate test and measurement equipment, select and evaluate suppliers, and manage quality agreements and supplier actions arising from goods inspection.
  • Develop and conduct training on QMS processes and policies, promoting regulatory requirements to all staff.

Minimum Criteria:

To be successful in this role, you should possess a relevant qualification from a reputable education organisation, along with at least 5 years' experience in quality management or a similar role. In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development, is essential.

Preferred Skills and Experience:

ISO 17955 Lead Auditor certification and quality management experience in product design and development are highly desirable.

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